CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Arm A - blood flow restriction training +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03364647
NCT03364647N/ACompleted

The Effect of Various Strength Training Protocols in ACL Reconstructed Participants

Brian W. Noehren·interventional·Posted Dec 6, 2017·Updated Jan 13, 2025

In Brief

A clinical study evaluating Arm A - blood flow restriction training and Arm B - standard of care for Anterior Cruciate Ligament (ACL) Tear and Physical Therapy. Completed, enrolled 55 participants across 2 sites.

Detailed Summary

The purpose of the study is to determine how two different blood flow restriction training programs used in conjunction with standard rehabilitation affect leg strength. By doing this study, the investigator hopes to learn if one program improves strength and function more than the other. The investigator also hope to learn how the training affects the properties of muscle in participants who will or have had anterior cruciate ligament (ACL) reconstruction. These results will help define how the training programs are working. There will be no charge to the participant for their physical therapy visits as long as they are part of the study The initial visit and follow up assessment at the end of the training will each take up to 6 hours (2 hours for MRI, 2 muscle biopsy, 2 for muscle strength, movement mechanics and questionaires). The physical therapy visits will range from 60-120 minutes depending on the participant's stage of recovery and the activities to engage in. Training sessions will be held 3 days a week for approximately 4 weeks before surgery and up to 24 weeks after surgery. There will be a total of 4 additional study visits over a 7 month period. The first visit will be used to capture baseline conditions of their knee and thigh muscles (muscle biopsy, MRI, strength). The second visit will occur right before surgery to assess changes during prehabilitation (strength and walking mechanics). The third visit will occur 4-5 months after surgery and will be a complete reevaluation of their thigh muscle and knee function (muscle biopsy, MRI, strength, gait). The last visit will occur 6-7 months after surgery and will involve an assessment of their thigh muscle strength, walking, and jumping form. The muscle biopsy and magnetic resonance imaging portion of the study will occur in the outpatient unit of the Center for Clinical and Translational Science at the UK Medical Center and the MRI center located on the medical center campus. The muscle biopsy will take an additional 15 minutes and the MRI up to two hours (1 hour per leg). It can take up to 4 hours total to complete both procedures. The investigator will accommodate participant preference for scheduling.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedDec 6, 2017
Enrollment StartAug 21, 2017
Primary CompletionOct 6, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 8.6 years ago

Interventions

Arm A - blood flow restriction trainingother

Group receive standard of care plus blood flow restriction training

Arm B - standard of careother

Group will receive standard of care plus a sham version of blood flow restriction training